Bactroban Cream

"Aug. 5, 2013 -- Anyone who develops a rash, blister, or some other skin reaction while taking acetaminophen should stop using the drug and seek medical care immediately. The painkiller poses the risk for three rare but potentially fatal skin diso"...

Bactroban Cream

WARNINGS

Avoid contact with the eyes.

In the event of a sensitization or severe local irritation from BACTROBAN CREAM (mupirocin calcium cream) , usage should be discontinued, and appropriate alternative therapy for the infection instituted.

PRECAUTIONS

General

As with other antibacterial products, prolonged use may result in overgrowth
of nonsusceptible microorganisms, including fungi. (See DOSAGE
AND ADMINISTRATION.) BACTROBAN CREAM (mupirocin calcium cream) is not formulated for use on mucosal
surfaces.

Carcinogenesis, Mutagenesis, Impairment of Fertility

Long-term studies in animals to evaluate carcinogenic potential of mupirocin
calcium have not been conducted.

Fertility studies were performed in rats with mupirocin administered subcutaneously
at doses up to 49 times a human topical dose of 1 gram/day (approximately 20
mg mupirocin per day) on a mg/m2 basis and revealed no evidence of
impaired fertility from mupirocin sodium.

Pregnancy

Teratogenic Effects: Pregnancy Category B. Teratology
studies have been performed in rats and rabbits with mupirocin administered
subcutaneously at doses up to 78 and 154 times, respectively, a human topical
dose of 1 gram/day (approximately 20 mg mupirocin per day) on a mg/m2
basis and revealed no evidence of harm to the fetus due to mupirocin. There
are, however, no adequate and well-controlled studies in pregnant women. Because
animal reproduction studies are not always predictive of human response, this
drug should be used during pregnancy only if clearly needed.

Nursing Mothers

It is not known whether this drug is excreted in human milk. Because many drugs
are excreted in human milk, caution should be exercised when BACTROBAN CREAM (mupirocin calcium cream)
is administered to a nursing woman.

Pediatric Use

The safety and effectiveness of BACTROBAN CREAM (mupirocin calcium cream) have been established in the
age groups 3 months to 16 years. Use of BACTROBAN CREAM (mupirocin calcium cream) in these age groups
is supported by evidence from adequate and well-controlled studies of BACTROBAN
CREAM in adults with additional data from 93 pediatric patients studied as part
of the pivotal trials in adults. (See Clinical
Studies.)

Geriatric Use

In 2 well-controlled studies, 30 patients older than 65 years were treated
with BACTROBAN CREAM (mupirocin calcium cream) . No overall difference in the efficacy or safety of BACTROBAN
CREAM was observed in this patient population when compared to that observed
in younger patients.

Last reviewed on RxList: 4/28/2009
This monograph has been modified to include the generic and brand name in many instances.